Blog - Royed Training

How to Make a Career in the Active Pharmaceutical Ingredients (API) Industry?

Posted on31 Dec 2024

TagsActive pharmaceutical Ingredients, API, API business development, api regulatory affairs

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The API industry is a cornerstone of the pharmaceutical sector, offering a wide array of career opportunities in areas such as manufacturing, quality assurance, regulatory...

What is active pharmaceutical ingredients?

Posted on31 Dec 2024

TagsActive pharmaceutical Ingredients, API, API business development

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Active Pharmaceutical Ingredients (APIs) are the biologically active components in a pharmaceutical drug that produce the intended effects. They are the essential substances in medicines...

API Business Development – Competency Test

Posted on20 Dec 2024

TagsAPI business development, api regulatory affairs

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The API Business Development – Competency Test is designed to evaluate your knowledge and skills in the dynamic and critical field of Active Pharmaceutical Ingredient...

Is it necessary to file suitability petition before RLD selection?

Posted on10 Dec 2024

TagsRLD, Suitability Petition

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No, it is not always necessary to file a suitability petition before selecting a Reference Listed Drug (RLD). However, there are specific circumstances where a...

How to learn pharma visual aid designing

How to learn : Preparing Pharma Visual Aid

Posted on09 Dec 2024

Tagspharma visual aid, pharma visual aid designing

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Creating an effective pharmaceutical visual aid requires a combination of creative, scientific, and marketing skills. A pharma visual aid (VA) is a marketing tool designed...

Career transitioning from Drug Regulatory Affairs to Biologic Regulatory Affairs

Posted on09 Dec 2024

Tagsbiologic regulatory affairs

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Moving from traditional drug regulatory affairs to biologic regulatory affairs is a strategic career pivot that can open up exciting opportunities in the rapidly growing...

what is the difference between 505j and 356h?

Posted on06 Dec 2024

Tags505j, Form 356h

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The difference between 505(j) and 356(h) lies in their purposes, regulatory pathways, and application forms in the context of the U.S. Food and Drug Administration...

Conversion of Vitamin A Retinol to Vitamin A palmitate – Palmitate mcg to IU

Posted on13 Nov 2024

Tagsmcg to IU

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The conversion of Vitamin A from its retinol form to palmitate form, as well as from micrograms (mcg) of Vitamin A palmitate to International Units...

The Importance of the XeVMPD System in EU Pharmacovigilance

Posted on10 Nov 2024

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The Extended EudraVigilance Medicinal Product Dictionary (XeVMPD) is a database used by pharmaceutical companies and regulatory authorities in the European Union to manage information about...

What is DMF retirement?

Posted on06 Nov 2024

TagsDMF, DMF annual update, DMF retirement

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DMF retirement” refers to the process by which a Drug Master File (DMF) is officially closed or deactivated by the regulatory authority (e.g., the FDA...